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Program Manager
Westmeath
Senior Buyer
Dublin
API Purchaser
Dublin
R&D Engineer
Dublin
QA Manager
Meath
QC Manager
Galway
R&D Engineer
Galway
QA Manager Biologics
Dublin West
QA Manager
Dublin West
Biostatistician
Dublin City Centre
QA Manager
Dublin North
Snr QA Specialist
Dublin South
Consultant
Brian Christensen
Life Science

+353 (0)1 685 47 47
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Search Results for Regulatory Affairs Officer
Job Title. Location Salary Actions

Regulatory Affairs Specialist

Regulatory Affairs Specialist Our client, a global medical device organisation requires a Regulatory Affairs Specialist to join their Regulatory Affairs Team. The Regulatory Affairs Specialist will report directly into the Regulatory Affairs Manager. Responsibilities • Maintain an excellent understanding of global medical device regulations for specific jurisdictions as assigned such as regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and FDA QSP 21CFR Part 820 as required • Ensure a thorough understanding of the products they are assigned...

Location: Limerick,
Regulatory Affairs Specialist
Limerick Not Disclosed

Senior Regulatory Compliance Officer

Senior Regulatory Compliance Officer Our client, a global healthcare organisation, requires a Senior Regulatory Compliance Officer to join their team for fixed term contract, the duration of which is 6 months. The successful candidate will manage, review registration information and provide this information to relevant departments, and to ensure regulatory compliance for all products released. Responsibilities • Manage the review of registration information supplied by various regional registration centres and provide the information as appropriate to the relevant...

Location: Dublin,
Senior Regulatory Compliance Officer
Dublin Not Disclosed
Other Regulatory Affairs Jobs
Job Title Location Salary Actions
Research and Development Compliance Specialist Galway Not Disclosed
Regulatory Affairs Specialist Galway Not Disclosed
Head of Quality & Regulatory Affairs Dublin Not Disclosed
Head of Quality & Regulatory Affairs Dublin Not Disclosed
Regulatory Affairs Specialist Galway Not Disclosed
Regulatory Affairs Specialist Galway Not Disclosed
Regulatory Affairs Specialist Galway Not Disclosed

Regulatory Affairs Officer Career Profile

Regulatory Affairs Officer


The Regulatory Affairs (RA) department is tasked with ensuring that the company complies with all of the local and international regulations and laws pertaining to their business. The Regulatory Affairs Officer works with international, state and local regulatory agencies, such as the Irish Medicines Board (IMB), the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) on specific issues affecting their business. The Regulatory Affairs Officer advises the company on the current regulatory aspects and climate that would affect proposed activities. The RA Officer has many interactions within the medical affairs dept. including medical information, pharmacovigilance and clinical trials.

Key responsibilities of the Regulatory Affairs Officer


  • Maintenance of Irish and overseas licenses including preparation of variation and renewal applications as appropriate.
  • Preparation and submission of Marketing Authorisation applications to EU regulatory authorities.
  • Preparation of dossiers to obtain CE marking for medical devices.
  • Ensuring Labelling complies with appropriate legislation.
  • Ensure approved regulatory requirements are enforced in-house.
  • Participate in the development of electronic submission of dossiers.
  • Provide support to R&D projects; including new product introductions, changes to existing products and processes.
  • Liaise with suppliers, clients, development partners and regulatory bodies.
  • Ensure guidelines and knowledge of legislation is current and be able to advise of future developments and changes.
  • Monitor the process of regulatory submissions, responding to queries and ensuring that registration approvals are granted without undue delay.